JP2024048935A - Fecal component extraction container - Google Patents

Abstract

[Problem] In the process of extracting fecal microbiota from feces, there was a demand for maintaining the activity of fecal microbiota, improving the efficiency of the extraction process, providing a container that is inexpensive and easy to handle, etc. [Solution] A soft, transparent fecal extraction container with an internal filter has three independent ventilation or liquid passage pipes on the side facing the extract liquid holding area, which makes it possible to achieve efficient work, maintain anaerobic conditions with minimal damage to the fecal microbiota, and prevent contamination by using pipes for different ventilation or liquid passage substances. [Selected Figure] Figure 1

Description

The present invention relates to an extraction container used in the process of extracting fecal components from collected feces.

In recent years, fecal microbial transplantation has been performed, in which fecal components are extracted from the stool of healthy donors and then transplanted into the intestines of patients to treat diseases.

One of the initial steps in this transplantation method is to extract fecal components from the donated feces using an extracting solution such as saline. However, due to the need to handle feces that emits a foul odor and to maintain the activity of the fecal microflora, it is desirable to carry out this process in a special, sealable container.

On the other hand, attempts have been made to prepare live bacterial preparations based on fecal components, and since extracts of fecal components obtained in a similar process are subjected to the preparation process, it is desirable to obtain a highly active fecal microbiota similar to that obtained with fecal microbial transplantation.

Claim 1 of Patent Document 1 describes an intestinal flora extraction container for extracting intestinal flora from stool,
A container body having a first opening and at least one second opening formed therein and configured to be deformable;
an opening/closing mechanism configured to open and close a first opening of the container body;
a filter member that is housed in the container body, divides the container body into a first region on the first opening side and a second region on the second opening side, and filters intestinal bacterial flora from the stool;
a communication member attached to the second opening and capable of communicating the second region with the outside of the container body;
"The gut microbiota extraction vessel is equipped with
However, the structure of the container used is complicated, and the work process for handling the container is far from simple.

Republished No. 2018-155614

The first of the required tasks is to obtain a more viable fecal microflora.
Obtaining highly active fecal microbiota through extraction can be expected to result in highly active fecal microbiota in the patient's intestines at the time of transplantation, allowing fecal microbial transplantation to achieve the maximum effect.

One method for maintaining high activity is to carry out the extraction in an anaerobic environment. This can reduce damage to the fecal microflora caused by oxygen, but making the entire work environment anaerobic requires large-scale equipment such as an anaerobic chamber or glove box, which is costly. In addition, these devices have limitations on their operation and are not easy to operate, so it is desirable to be able to maintain a sufficient anaerobic environment inside the extraction container even during normal indoor work.

A second challenge is to obtain larger amounts of fecal microbiota.
By collecting more stool from a donor, a larger amount of stool extract can be secured, allowing more patients to be treated more frequently.

In order to obtain a large amount of fecal microbiota, it is necessary to improve the efficiency of the extraction process and the throughput in response to the increase in the number of donors and the frequency of donation.
For this purpose, it is desirable that the extraction vessel used be inexpensive and available in large quantities, be lightweight and easy to handle, and realize a short extraction operation time.

The invention described in claim 1 is
A container for extracting fecal components from collected feces,
It is made of a deformable soft material,
The inside of the container is divided into a stool holding area and a stool extract holding area by a filter that filters out undigested material in the stool.
The fecal extract holding area has three independent ventilation or liquid passage pipes capable of passing gas or liquid therethrough;
The container is characterized by the above.

The material of the container used is soft, lightweight, and easy to handle, and it is preferable that the container is transparent so that the inside of the container can be observed during work.
Furthermore, it is more preferable that the container can be sealed by heat sealing and has gas barrier properties.

The extraction container body is advantageous in terms of material processing, work efficiency, etc. when it has a shape of two rectangular planar members with the four sides sealed, but since it is advantageous to have a moderate thickness near the attachment position of the ventilation or liquid passage pipe and near the feces holding position, a structure with gussets is desirable. On the other hand, when sealing and cutting the area between the feces extract holding area and the feces holding area after extraction, a structure without gussets that is close to flat near the sealing and cutting positions is desirable in order to achieve favorable performance of heat sealing and cutting.
Furthermore, if the entire extraction vessel is integrally molded from a single material, it is advantageous in terms of light weight, ease of handling, and a small number of parts.

Specific examples include low-density polyethylene, high-density polyethylene, linear low-density polyethylene, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, ionomer, non-oriented polypropylene, polyvinylidene chloride-coated tensile polypropylene, coated polyester, and films made by laminating these films.

The size of the container to be used is not particularly limited, but from the viewpoint of ease of handling, a length of about 100 mm to 1,000 mm and a width of about 100 mm to 1,000 mm are preferable. Taking into consideration the amount of stool and extract to be treated at one time and the size of the machine used for heat sealing, a length and width of about 150 mm to 200 mm are more preferable.
The shape does not have to have a gusset, but having a gusset will increase the content volume relative to its length and width, improving work efficiency.

The material of the filter to be used is not particularly limited, and the pore size may be any size that allows microorganisms to pass through, and preferably has a pore size that does not cause clogging with undigested substances in stool.
Specifically, materials that can be welded to the film by heat sealing, such as nonwoven fabric, filter paper, cloth, hollow fiber, and polyamide mesh, are preferably used.

The extraction solution used may be physiological saline, which is usually used as a buffer. It is preferable to add a cryoprotectant such as glycerol, polyethylene glycol, trehalose, or a combination of these.

The three independent ventilation or liquid passage pipes may be attached in any order, but may be used individually depending on the purpose of use.
The first ventilation or liquid passage pipe is used to inject an extract into the container after the stool has been inserted, to remove air, and to fill the container with nitrogen.
The second ventilation or liquid passage pipe is used to remove nitrogen after the stool extract is suspended.
The third ventilation or liquid passage pipe is used to transport the fecal extract containing the extracted fecal components from the fecal extract holding area to the outside.
The positions of the three vent or liquid passage pipes may be arbitrary, but contamination can be avoided by using different vent or liquid passage pipes for each process.

The invention described in claim 2 is
2. The container according to claim 1, wherein the feces holding area has a feces insertion opening that allows feces to be inserted through an opening and can be sealed after insertion.

After the stool is inserted, the stool insertion opening can be sealed by any method, such as with an adhesive, but sealing by heat sealing is preferred for work efficiency.

The invention described in claim 3 is
3. The container according to claim 2, wherein the gas or liquid passage pipe is normally closed and opens only when gas or liquid is to pass through.

The invention described in claim 4 is
4. The container according to claim 2 or 3, wherein the fecal extract holding region is capable of isolating and sealing the fecal extract holding region from the filter, and the fecal extract holding region and the filter portion can be removed after sealing.

For efficiency, it is preferable to use heat sealing for sealing. By cutting the container to leave only the area that holds the stool extract, the container containing the extracted stool microflora can be provided for the subsequent process.

It is possible to provide an extraction vessel which is flexible, easy to handle, does not require special working techniques, and shortens working time.
Furthermore, the fecal microbiota processed in this extraction vessel can be subjected to subsequent processes in a state in which its activity is maintained due to the anaerobic environment, which can contribute to improving the overall quality of fecal microbial transplantation.

FIG. 1 is a perspective view of an extraction vessel according to the present invention. FIG. 2 is a plan view and a cross-sectional view taken along line A--A of the extraction vessel of the present invention. FIG. 3 is a perspective view of the feces insertion opening side of the extraction container according to the fourth aspect of the present invention. FIG. 4 is a perspective view of the opposite side of the extraction vessel according to the fourth aspect of the present invention. FIG. 5 is a plan view and a cross-sectional view taken along line AA of an extraction vessel according to the fourth aspect of the present invention. FIG. 6 is a detailed view of three vent or liquid passage pipes.

Hereinafter, embodiments of the present invention will be described. However, each specific description is one example for realizing the present invention, and the present invention is not limited to these specific examples. Any other specific examples that can realize the general technical idea of the present invention are also included in the present invention.
It is preferable that the connectors of the three ventilation or liquid pipes in the extraction vessel of the present invention are of different types, since this contributes to reducing human error.

To explain this in more detail with reference to Figure 6, of the three vent or liquid passage pipes, which are distinguished by purpose regardless of their installation position, a swabbable valve can be used for the first vent or liquid passage pipe. A male Luer fitting can be connected as the connection destination, and three pipes with male Luer fittings are prepared as connection destinations for the first vent or liquid passage pipe's intended uses of injecting the extract, degassing the air, and filling with nitrogen.

The swabbable valve normally maintains a closed state without the need for a sealing means such as a pinch cock, and transitions to an open state when a male luer fitting is connected. Therefore, the desired ventilation or liquid passage can be performed simply by connecting and disconnecting the necessary external pipes, allowing for efficient work when performing multiple operations. Furthermore, there is no risk of unintended release to the outside air due to incorrect operation of the sealing means.

Next, a male Luer fitting can be used for the second vent or liquid passage pipe. The second vent or liquid passage pipe is used only for degassing, and is not particularly connected to an external pipe, as the nitrogen inside the extraction vessel is discharged to the outside air by compressing the vessel. For this reason, male Luer fittings cannot be connected to each other, so there is no risk of accidentally connecting an external pipe.

Finally, the third vent or liquid passage pipe can use a female Luer fitting. When transferring the stool extract after the extraction process to the outside of the extraction container, a pipe with a male Luer fitting for transfer is connected and used. The shape is significantly different from the first vent or liquid passage pipe, so there is little risk of confusion.
In addition, by using different ventilation or liquid passage pipes depending on the purpose, contamination can also be prevented.

The extraction process using the extraction vessel of the present invention will be described with reference to the extraction vessel shown in FIGS.
First, feces 5 are inserted through feces insertion port 4 into a feces holding area separated by filter 3 inside the container.
Next, the feces insertion opening 4 is sealed at the position aa by heat sealing or the like.
Next, the extract 6 is injected through the first aeration or liquid passage pipe, the air inside is sucked out through the same pipe with a pump, and a certain amount of nitrogen is injected through the same pipe to secure a head space in the upper part of the container. This increases the degree of freedom of movement within the container, making it easier to suspend the feces and extract. Also, since there is no oxygen, an anaerobic environment is realized.

Next, the extraction container is deformed by applying external pressure, thereby mixing the stool with the extract, and suspending and dissolving the components in the stool from the stool into the extract.
Next, the nitrogen used as the head space is discharged from the second ventilation or liquid passage pipe by applying pressure to the container, thereby strengthening the anaerobic environment.
Finally, the fecal extract after extraction is transferred to an external container while still in an anaerobic environment through the third ventilation or liquid passage pipe.

The extraction process using the extraction vessel according to claim 4 of the present invention will be described with reference to the extraction vessel shown in FIGS.
Basically, the extraction operation is carried out in the same manner as in Example 1, but immediately after the completion of the extraction, the fecal extract is not transferred from the third ventilation or liquid passage pipe, and instead, position b--b is blocked and sealed by heat sealing or the like, and the fecal extract holding area and the filter portion are cut off from the fecal extract holding area at the same position.

The fecal extract holding area with the remaining ventilation or liquid passage pipe is sealed in an anaerobic state, and in some cases can be used as a fecal extract storage container for subsequent work steps, such as by freezing it. Of course, when transferring the fecal extract from this container to the outside, the third ventilation or liquid passage pipe is used.

The extraction container of the present invention makes it possible to obtain fecal microbiota that is fresh, and the extraction procedure is simple and efficient. The container is inexpensive, lightweight, and easy to handle, which brings about an economical effect on the entire fecal microbial transplantation process.

1 Extraction vessel body 2 Ventilation or liquid passage pipe 3 Filter 4 Feces insertion port 5 Feces 6 Extraction liquid 7 Swabable valve 8 Female luer fitting 9 Male luer fitting a Sealed position after feces insertion b Sealed and cut position after extraction

Claims (4)

A container for extracting fecal components from collected feces,
It is made of a deformable soft material,
The inside of the container is divided into a stool holding area and a stool extract holding area by a filter that filters out undigested material in the stool.
The fecal extract holding area has three independent ventilation or liquid passage pipes capable of passing gas or liquid therethrough;
A container characterized by: The container according to claim 1, which has a feces insertion opening in the feces holding area that can be sealed after feces is inserted through an opening. The container according to claim 2, wherein the ventilation or liquid passage pipe is normally closed and opens only when gas or liquid is passing through. The container according to claim 2 or 3, in which the fecal extract holding area can be sealed off from the fecal holding area and the filter, and the fecal holding area and the filter can be cut off after sealing.

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